Dendreon Reports First Quarter 2008 Financial Results

SEATTLE, May 8 /PRNewswire-FirstCall/ -- Dendreon Corporation NASDAQ: DNDN today reported results for the first quarter ended March 31, 2008. Revenue for the first quarter of 2008 was $31,000 compared to $80,000 for the quarter ended March 31, 2007.

Dendreon's total operating expenses for the three months ended March 31, 2008 were $19.2 million compared to $32.0 million for the same period in 2007. The significant reduction primarily relates to a decrease of $6.5 million associated with purchases of commercial scale quantities of the antigen used in connection with Dendreon's lead investigational product, Provenge(R) (sipuleucel-T) as well as reduced expenses associated with the IMPACT clinical trial which completed enrollment in October of 2007. The net loss for the quarter ended March 31, 2008 was $19.5 million, or $0.23 per share compared to a net loss for the same quarter of 2007 of $30.9 million, or $0.38 per share, which includes $0.08 per share associated with commercial antigen purchases. Cash, cash equivalents, short-term, and long-term investments at March 31, 2008 totaled $99.5 million compared to $120.6 million at December 31, 2007. Subsequent to March 31, 2008, the Company received approximately $46 million of net proceeds from the registered direct offering that closed on April 8, 2008.

"We had a very productive first quarter, highlighted by our amended Special Protocol Assessment (SPA) for our ongoing Phase 3 clinical study that accelerates our timeline for final results by a year. At Dendreon, our primary focus remains on providing the FDA with the additional clinical data that it needs to support the approval of PROVENGE so that we may offer this promising therapy to the many men with prostate cancer who currently have few appealing treatment options," stated Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We remain in line with our previous financial and operational guidance for 2008, and as a result of our recent financing, we expect to have sufficient resources to carry us through the final analysis of our Phase 3 IMPACT study."

    Recent Events:

    -- The FDA agreed to amend the IMPACT (IMmunotherapy for Prostate
       AdenoCarcinoma Treatment) SPA, accelerating the expected timeline for
       final results from the study by approximately one year while
       maintaining comparable power to the previous SPA.  In addition, the FDA
       reconfirmed that either a positive interim or final analysis of
       survival would support licensure and enable Dendreon to amend the
       Company's biologics license application for PROVENGE.
    -- Completed a registered direct stock offering resulting in the receipt
       of net proceeds of approximately $46 million.  With this cash infusion,
       the Company has adequate resources to complete the IMPACT trial and
       finance operations through the final analysis of that trial.
    -- Presented clinical data from a Phase 1 trial of Neuvenge(TM)
       (lapuleucel-T) demonstrating that the Active Cellular Immunotherapy,
       which is based on the same Antigen Delivery Cassette(TM) technology as
       PROVENGE, may not only have potential clinical benefit in breast
       cancer, but also in ovarian and colorectal cancers.  These data were
       presented in April at the American Association for Cancer Research
       annual meeting.
    -- In lieu of Dendreon's regularly scheduled quarterly conference call,
       the Company will present at several upcoming investor conferences that
       will be webcast, two of which are later this month and include:

       - Bank of America Health Care Conference on May 13, 2008
       - The Rodman & Renshaw 5th Annual Global Healthcare Conference on
         May 19, 2008

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics to fight cancer. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov.

                             DENDREON CORPORATION
                    CONSOLIDATED STATEMENTS OF OPERATIONS
                   (in thousands, except per share amounts)

                                                  Three months ended March 31,
                                                       2008          2007

    Revenue                                              $31            $80

    Operating expenses:
      Research and development                        13,478         24,962
      General and administrative                       5,675          7,075
    Total operating expenses                          19,153         32,037
    Loss from operations                             (19,122)       (31,957)
    Interest income                                    1,137          1,392
    Interest expense                                  (1,531)          (293)
    Net loss                                        $(19,516)      $(30,858)


    Basic and diluted net loss per share              $(0.23)        $(0.38)

    Shares used in computation of basic and
      diluted net loss per share                      83,313         81,577



                                                     March 31,    December 31,
                                                       2008           2007
    Balance Sheet Data:
    Cash and cash equivalents                        $63,214        $75,721
    Short-term investments                            23,552         27,115
    Long-term investments                             12,775         17,739
    Total assets                                     138,174        161,662
    Convertible senior subordinated notes             85,250         85,250
    Total stockholders' equity                        22,625         40,377